Status
Ongoing
Drug Enforcement D-0776-2023
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Classification
Class II
Report Date
June 7, 2023
Termination Date
—
Product Information
- Product description
- HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2
- Product quantity
- 3,232 syringes
- Reason for recall
- CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed in Missouri.
Location & Firm
- Recalling firm
- SSM Health Care St. Louis DBA SSM St. Clare Health Center
- Address
-
1015 Bowles Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0776-2023
- Event ID
- 92395
- Recall initiation date
- May 9, 2023
- Center classification date
- May 31, 2023
- Code info
- Lot #: 20230222-45AB24, BUD: 8/21/2023; Lot #: 20230110-058361, BUD: 7/9/2023; Lot #: 20221208-0F5483, BUD: 6/6/2023; Lot #: 20221109-45BA60, BUD: 5/8/2023; Lot #:20220929-523FD5, BUD: 3/28/2023; Lot#: 20220914-5D5AE0, BUD: 3/13/2023; Lot #: 220502-024, BUD: 10/29/2022; Lot #: 220510-035, BUD: 11/6/2022; Lot #: 220526-015, BUD: 11/22/2022; Lot#: 220811-010, BUD: 2/7/2023
- More code info
- —